ALX Oncology Holdings Inc. (ALXO) has announced the top-line data from its ASPEN-06 Phase 2 trial, demonstrating that Evorpacept significantly enhances tumor response in patients with HER2-positive gastric cancer. The trial results indicate notable clinical improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
On Wednesday, ALXO closed regular trading at $4.80, reflecting a decline of $0.65 or 11.93%. In after-hours trading, the stock further decreased by $1.36 or 28.33%.
The company highlighted that the combination of Evorpacept achieved a confirmed overall response rate (ORR) of 40.3%, compared to 26.6% in the control group, and exhibited a median duration of response of 15.7 months, significantly longer than the 7.6 months observed in the full trial population.
In the pre-specified cohort of patients with fresh HER2-positive biopsies, the Evorpacept combination yielded the most substantial benefit, with an ORR of 54.8% compared to 23.1% in the control group. This suggests that HER2 expression is strongly correlated with Evorpacept efficacy, validating its mechanism of action.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Moreover, both the FDA and the European Commission have awarded Orphan Drug Designation for this indication.
